Over 600,000 nosocomial (hospital-acquired) urinary tract infections are developed per year. This constitutes approximately 40% of all infections developed in hospitals, with such infections normally requiring treatment involving hospitalization for several days at costs which have been averaging $1,000 per incidence.
One of the primary causes of urinary tract infections is the entry of bacteria into the established drainage system at the point of connection between the Foley catheter and the tubing connector or drainage tube adaptor.
This point of joining between the catheter and the tubing connector has been found to be particularly troublesome in that disconnection, either accidentally or intentionally without authorization, frequently occurs. This not only greatly increases the possibility of bacteria entering into the established drainage system, but also could have a serious effect on any flow metering or measuring which might be involved. For example, in the management of some patients, it is very essential that the urine output be accurately measured. Thus, a urine meter will normally be interposed between the catheter and collection bag. Any tampering with the catheter connection to the drainage system would affect the readings obtained and could in turn have an adverse effect on patient management.
While systems have heretofore been used which have been referred to as "preconnected" systems, such merely involved preconnecting the catheter to the drainage bag or drainage tube adaptor by conventional telescopic frictional engagement at the point of assembly or manufacture. No provision was made for preventing disconnection, preventing tampering with the connection, or providing evidence of either tampering or disconnection.